Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis

NCT00420251 | Completed Phase 3

• 1 other identifier: 13042004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Growth retardation is well known in patients with severe forms of juvenile idiopathic arthritis. Especially those who were under additional treatment with glucocorticoids for high disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part, overcome growth hormone resistance state and increase final height. In a controlled study we follow patients with juvenile idiopathic arthritis with and without growth hormone treatment until final height. Additionally, we are interested in bone density development in those treated with growth hormone.

Conditions

Juvenile Idiopathic Arthritis; Still Disease, Juvenile-Onset

Outcome Measures

Primary Outcomes (1)

• Final height

Secondary Outcomes (1)

• Bone geometry and density

Interventions

Genotropin DRUG

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Polyarticular or systemic juvenile idiopathic arthritis,
• Growth velocity below the 25th percentile and or short stature ,
• Prepubertal stage,
• Bone age below 10 in girls and 12 in boys,
• Growth hormone levels after stimulation with clonidine or arginine above 10 ng/ml

You may not qualify if:

• Previous treatment with growth hormone,
• Endocrinopathy,
• Additional chronic disease beside juvenile idiopathic arthritis,
• Malignant disase,
• Chromosomal aberration or othe syndromal disease,
• Previous treatment with Oxandrolone,
• Small for gestational age,
• Elevated fasting glucose level

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Pfizer: collaborator

Study Sites (1)

Center For Rheumatic Diseases in Childhood

Garmisch-Partenkirchen, 82152, Germany

Location

Related Publications (2)

• Bechtold S, Ripperger P, Muhlbayer D, Truckenbrodt H, Hafner R, Butenandt O, Schwarz HP. GH therapy in juvenile chronic arthritis: results of a two-year controlled study on growth and bone. J Clin Endocrinol Metab. 2001 Dec;86(12):5737-44. doi: 10.1210/jcem.86.12.8083.

  PMID: 11739431 RESULT

• Bechtold S, Ripperger P, Hafner R, Said E, Schwarz HP. Growth hormone improves height in patients with juvenile idiopathic arthritis: 4-year data of a controlled study. J Pediatr. 2003 Oct;143(4):512-9. doi: 10.1067/S0022-3476(03)00390-1.

  PMID: 14571231 RESULT

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Susanne M Bechtold, MD

  University Children´s Hospital, Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: March 1, 1996
• Study Completion: July 1, 2006
• Last Updated: January 11, 2007

Record last verified: 2007-01

Locations

DE (1)